Last updated on October 2018

PERIGON Japan Trial

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.

Detailed Study Description

This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.

Clinical Study Identifier: NCT02686814

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Yoshiaki Fukumura, MD

Tokushima Red Cross Hospital
Tokushima, Japan

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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